newsfilter
← Latest News
GlobeNewswire·

Radiopharm Theranostics Announces Positive Phase 2b Trial Results of RAD 101 for Diagnosis of Brain Metastases

RADX
  • RAD101 achieved 93% concordance with MRI across all evaluable lesions, meeting the Phase 2b trial primary endpoint.
  • Preliminary secondary objective data from 14 patients with six-month follow-up or biopsy results show 86% sensitivity.
  • Specificity data for RAD101 is expected to be available in Q4 2026.
  • The company plans to advance RAD101 into a U.S. Phase 3 pivotal trial in Q4 2026.
  • RAD101 targets fatty acid synthase (FASN) to diagnose suspected recurrent brain metastases from solid tumors.
  • The U.S. brain metastases imaging market is valued at over $600 million with no currently approved PET product.
  • RAD101 holds FDA Fast Track Designation to differentiate recurrent disease from treatment effects.
  • A partnership with Siemens Healthineers has been established for the manufacturing distribution of 18F-labeled RAD101 doses.
  • The Phase 2b trial was a U.S. multicenter open-label single-arm study involving 30 evaluable patients with suspected recurrence post-radiotherapy.
  • CE-MRI remains the preferred imaging method for intracranial metastatic disease but has limitations in distinguishing recurrence from treatment effects.